Infusion devices and related consumable calibration methods

ABSTRACT

Infusion systems including infusion devices and consumables and related operating methods are provided. An exemplary method of operating an infusion device operable to deliver a fluid influencing a physiological condition to a body of a user involves a control module of the infusion device obtaining calibration data associated with a consumable coupled to the infusion device via an interface of the infusion device, determining a delivery command for delivering the fluid to the body of the user based at least in part on the calibration data, and operating a pumping mechanism to deliver the fluid from a reservoir of the consumable to the body of the user in accordance with the delivery command.

CROSS-REFERENCE TO RELATED APPLICATIONS

The subject matter described here is related to the subject matterdescribed in U.S. patent application Ser. No. 15/427,019, filedconcurrently herewith.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tomedical devices, and more particularly, embodiments of the subjectmatter relate to operation of a fluid infusion device usingpre-calibrated consumables.

BACKGROUND

Infusion pump devices and systems are relatively well known in themedical arts, for use in delivering or dispensing an agent, such asinsulin or another prescribed medication, to a patient. A typicalinfusion pump includes a pump drive system which typically includes asmall motor and drive train components that convert rotational motormotion to a corresponding delivery of medication from a reservoir to thebody of a user via a fluid path created between the reservoir and thebody of a user. Use of infusion pump therapy has been increasing,especially for delivering insulin for diabetics. Continuous insulininfusion provides greater control of a patient with diabetes glucoselevels, and hence, control schemes are being developed that allowinsulin infusion pumps to monitor and regulate a user's blood glucoselevel in a substantially continuous and autonomous manner.

In practice, it is desirable to accurately monitor and control thevolume of fluid delivered to the user. However, designing a flow meteror similar component than can accurately cover the entire range ofincremental amounts of fluid that may be delivered in a single deliveryoperation may be costly or problematic once durability, reliability andother constraints are considered. Moreover, the design of the flow metermay be further complicated by the form factor of the infusion device orother packaging constraints. Additionally, depending on the type of pumpor fluid delivery technology employed, the flow meter may contact thefluid being infused, which, in turn, may require periodic replacement ordisposal of the flow meter or some of its components. Accordingly, thereis a need to accurately monitor and control the volume of fluiddelivered without compromising device form factor or incorporating apotentially costly flow meter or similar component that satisfies thevarious requirements that may be imposed.

BRIEF SUMMARY

Infusion systems, infusion devices, consumables, and related operatingmethods are provided. An embodiment of a method of operating an infusiondevice to deliver fluid capable of influencing a physiological conditionto a body of a user is provided. The method involves obtaining, by acontrol module of the infusion device via an interface of the infusiondevice, calibration data associated with a consumable coupled to theinfusion device, determining, by the control module, a delivery commandfor delivering the fluid to the body of the user based at least in parton the calibration data, and operating, by the control module, a pumpingmechanism to deliver the fluid from the consumable in accordance withthe delivery command. Thus, the amount or rate of fluid delivered may beinfluenced by the calibration data.

In another embodiment, an apparatus for an infusion device is provided.The infusion device includes a housing including a portion for receivinga consumable, an interface proximate the portion of the housing toobtain configuration data from the consumable, an actuation arrangementcontained within the housing and configured to actuate a pumpingmechanism operable to dispense a fluid from the consumable, and acontrol module coupled to the interface and the actuation arrangement todetermine a delivery command based at least in part on the calibrationdata and operate the actuation arrangement in accordance with thedelivery command.

In another embodiment, an infusion system is provided. The systemincludes a consumable including a pumping mechanism for dispensing afluid and a readable element maintaining calibration data characterizinga relationship between delivery of the fluid and actuation of thepumping mechanism. The system also includes an infusion device includingan interface to obtain the calibration data from the readable element,an actuation arrangement configured to actuate the pumping mechanism,and a control module coupled to the interface and the actuationarrangement to determine a delivery command based at least in part onthe calibration data and operate the actuation arrangement in accordancewith the delivery command.

In another embodiment, an apparatus for a consumable component isprovided. The consumable component includes a housing, a reservoircontained within the housing, a pumping mechanism for dispensing a fluidfrom the reservoir, and a readable element associated with the housing,the readable element maintaining calibration data characterizing arelationship between delivery of the fluid and actuation of the pumpingmechanism.

A method of manufacturing a consumable component including a pumpingmechanism is also provided. The method involves actuating, by a controlmodule, the pumping mechanism of the consumable component by a referenceamount, obtaining, by the control module from a sensing arrangement, ameasured response to the reference amount, determining, by the controlmodule, calibration data associated with the consumable based on therelationship between the measured response and the pumping mechanism,and writing, by the control module, the calibration data to a readableelement associated with the consumable.

In yet another embodiment, a system is provided that includes aconsumable and an infusion device. The consumable includes a housingcontaining a reservoir and a pumping mechanism in fluid communicationwith the reservoir to dispense a fluid from the reservoir, and areadable element associated with the housing. The readable elementmaintains calibration data characterizing a relationship betweendelivery of the fluid and actuation of the pumping mechanism. Theinfusion device is configured to receive the housing and includes aninterface to obtain the calibration data from the readable element,wherein the calibration data influences operation of the pumpingmechanism by the infusion device.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures, which may beillustrated for simplicity and clarity and are not necessarily drawn toscale.

FIG. 1 depicts an exemplary embodiment of an infusion system;

FIG. 2 is a flow diagram of an exemplary control process suitable foruse with the infusion system of FIG. 1 in one or more exemplaryembodiments;

FIG. 3 is a flow diagram of an exemplary calibration process suitablefor use with the control process of FIG. 2 in one or more exemplaryembodiments;

FIG. 4 depicts a plan view of a fluid infusion device and consumablesuitable for use in the infusion system of FIG. 1 in conjunction withthe control process of FIG. 2 and the calibration process of FIG. 3 inaccordance with one or more embodiments;

FIG. 5 depicts a plan view of a piston pumping mechanism suitable forimplementation in the consumable of FIG. 4 in accordance with one ormore embodiments;

FIG. 6 depicts a plan view of another embodiment of a fluid infusiondevice and consumable suitable for use in the infusion system of FIG. 1in conjunction with the control process of FIG. 2 and the calibrationprocess of FIG. 3 in accordance with one or more embodiments where thepumping mechanism is realized as a peristaltic pumping mechanismintegrated with the consumable;

FIG. 7 depicts a detail view of the peristaltic pumping mechanism in theinfusion system of FIG. 6 in accordance with one or more embodiments;

FIG. 8 depicts a plan view of another embodiment of a fluid infusiondevice and consumable that cooperatively support a peristaltic pumpingmechanism suitable for use in conjunction with the control process ofFIG. 2 and the calibration process of FIG. 3 in accordance with one ormore embodiments;

FIG. 9 depicts a detail view of the peristaltic pumping mechanism in theinfusion system of FIG. 8 in accordance with one or more embodiments;and

FIG. 10 depicts an exemplary embodiment of a fluid delivery systemsuitable for implementation in the infusion system of FIG. 1 inconjunction with the control process of FIG. 2 and the calibrationprocess of FIG. 3 in accordance with one or more embodiments.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

While the subject matter described herein can be implemented in anyelectronic device, exemplary embodiments described below are implementedin the form of medical devices, such as portable electronic medicaldevices. Although many different applications are possible, thefollowing description focuses on a fluid infusion device (or infusionpump) as part of an infusion system deployment. For the sake of brevity,conventional techniques related to infusion system operation, insulinpump and/or infusion set operation, and other functional aspects of thesystems (and the individual operating components of the systems) may notbe described in detail here. Examples of infusion pumps may be of thetype described in, but not limited to, U.S. Pat. Nos. 4,562,751;4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798;6,558,320; 6,558,351; 6,641,533; 6,659,980; 6,752,787; 6,817,990;6,932,584; and 7,621,893; each of which are herein incorporated byreference.

Embodiments of the subject matter described herein generally relate toinfusion systems including a fluid infusion device having an actuationarrangement that is operable to actuate a mechanism that facilitatesdelivering a dosage of fluid, such as insulin, from a reservoir to abody of a patient (or user) via an infusion arrangement, such as aneedle, cannula, infusion set, or the like. Dosage (or delivery)commands that govern operation of the motor may be generated in anautomated manner in accordance with the delivery control schemeassociated with a particular operating mode, and the dosage commands maybe generated in a manner that is influenced by a current (or mostrecent) measurement of a physiological condition in the body of theuser. For example, in a closed-loop operating mode, dosage commands maybe generated based on a difference between a current (or most recent)measurement of the interstitial fluid glucose level in the body of theuser and a target (or reference) glucose value. In this regard, the rateof infusion may vary as the difference between a current measurementvalue and the target measurement value fluctuates. For purposes ofexplanation, the subject matter is described herein in the context ofthe infused fluid being insulin for regulating a glucose level of a user(or patient); however, it should be appreciated that many other fluidsmay be administered through infusion, and the subject matter describedherein is not necessarily limited to use with insulin.

As described in greater detail below, in exemplary embodiments describedherein, the fluid infusion device receives a consumable that is disposedof, changed or otherwise replaced periodically. As used herein, aconsumable should be understood as referring to any element or componentthat is capable of being detachably engaged with, inserted into, orcoupled to the fluid infusion device to support delivery of fluid. Inexemplary embodiments, the consumable includes a fluid reservoir and isdisposed of or replaced upon depletion of the fluid reservoir.

In exemplary embodiments, the consumable includes a readable element orsimilar feature that stores or otherwise maintains configurationinformation associated with the consumable. In this regard, theconfiguration information is utilized by the infusion device toinfluence operation of the infusion device to deliver fluid. Forexample, the configuration information may quantify or otherwisecharacterize an amount or rate of fluid deliverable from the consumableper a unit of actuation of a pumping mechanism configured to dispensefluid from the reservoir, with a control module of the infusion deviceusing the configuration information to modulate actuation of the pumpingmechanism to achieve a desired amount or rate of fluid delivery inaccordance with the configuration information. Thus, an infusion devicemay be capable of supporting consumables having pumping mechanisms ofdifferent sizes or dimensions. For example, one version of a consumablecomponent may be configured to deliver 0.25 units of insulin for a givenamount of actuation of its associated pumping mechanism (e.g., perstroke of a piston in a piston pump), while a second version of theconsumable component is configured to deliver one unit of insulin forthe same amount of actuation of its associated pumping mechanism.Similarly, dimensions of the tubing or fluid conduits associated with aperistaltic pump may be similarly varied but accounted for viaassociated calibration data, thereby enabling an infusion device tosupport different tube diameters of different consumables that may beutilized with the infusion device.

In exemplary embodiments, the fluid infusion device includes aninterface that is configured to read, scan, engage, or otherwise accessthe readable element of the consumable, and thereby, allow the controlmodule of the fluid infusion device to obtain the consumableconfiguration information from the readable element via the interface.Thus, when the consumable engaged with the infusion device is changed,the control module may update the consumable configuration informationbeing utilized onboard the infusion device by retrieving configurationinformation associated with the current consumable and thereafterutilize the updated consumable configuration information to adjustactuation of the pumping mechanism and achieve a desired amount or rateof fluid delivery from the new consumable. In this regard, updating theconfiguration information accounts for variations from one consumable tothe next and allows the infusion device to modify actuation to maintainconsistent control and delivery of fluid independent of the consumablevariations.

For example, as described in the context of FIGS. 4-5, in oneembodiment, the pumping mechanism is realized as a piston pumpintegrated with the reservoir as part of the consumable, where theconfiguration information associated with the consumable indicates thevolume of fluid delivered per stroke (or stroke increment) of thepiston. In this regard, different instances of the piston pump maydeliver different amounts of fluid based on variations in the dimensionsof the chamber, ports or valves, the piston, and other components of thepiston pump. Accordingly, each consumable is pre-calibrated to identifythe volume of fluid delivered per stroke (or stroke increment) of itsassociated piston. The infusion device reads the stroke calibrationinformation and for a given amount of fluid to be delivered, calculatesthe appropriate number of strokes (or stroke increments) to achieve adesired amount of fluid using the current consumable. Accordingly, themanufacturing tolerances and other requirements for the piston and othercomponents of the pumping mechanism may be relaxed and compensated forby the calibration information, thereby reducing costs and complexity ofthe consumable without compromising control of fluid delivery.

In another example embodiment, as described in the context of FIGS. 6-9,in other embodiments, the pumping mechanism is realized as a peristalticpump includes a fluid tube from the reservoir of the consumable. In suchembodiments, the configuration information associated with theconsumable indicates the volume of fluid delivered per rotation (orincrement thereof) of the rotor of the peristaltic pumping mechanism. Inthis regard, the dimensions (e.g., the diameter) of the fluid tube mayvary across instances of consumables, so that different rates or amountsof fluid may be delivered as the rotor rotates. Thus, each consumable ispre-calibrated to identify the volume of fluid delivered per rotation(or rotational increment). Depending on the embodiment, the rotor of theperistaltic pumping mechanism may be integrated with the infusion deviceor the consumable. In embodiments where the rotor of the peristalticpump is integrated with the consumable, it should be appreciated thatthe calibration information accounts not only for variations in thefluid tube dimensions across consumables, but also variations associatedwith the peristaltic pump rotor across consumables. Accordingly, themanufacturing tolerances and other requirements for the tubing, theperistaltic pump rotor (when part of the consumable), and othercomponents of the consumable may be relaxed and compensated for by thecalibration information, which, again, may reduce cost and complexitywithout compromising fluid delivery.

FIG. 1 depicts an exemplary embodiment of an infusion system 100 thatincludes, without limitation, a fluid infusion device 102, a sensingarrangement 104, and a consumable component 106. The fluid infusiondevice 102 and the consumable component 106 cooperate to deliver fluidfrom a reservoir 108 of the consumable 106 to the body 110 of a user (orpatient). The components of an infusion system 100 may be realized usingdifferent platforms, designs, and configurations, and the embodimentsdepicted herein are not exhaustive or limiting. In practice, theinfusion device 102 and the sensing arrangement 104 may be secured atdesired locations on the body 110 of the user. In this regard, theinfusion device 102 is designed as a portable medical device suitablefor infusing a fluid, a liquid, a gel, or other agent into the body of auser. In exemplary embodiments described herein, the infused fluid isinsulin, although many other fluids may be administered through infusionsuch as, but not limited to, HIV drugs, drugs to treat pulmonaryhypertension, iron chelation drugs, pain medications, anti-cancertreatments, medications, vitamins, hormones, or the like. In someembodiments, the fluid may include a nutritional supplement, a dye, atracing medium, a saline medium, a hydration medium, or the like.

In exemplary embodiments, the infusion device 102 is capable ofcontrolling or otherwise regulating a physiological condition in thebody 110 of a user to a desired (or target) value or otherwise maintainthe condition within a range of acceptable values in an automated orautonomous manner. In one or more exemplary embodiments, the conditionbeing regulated is sensed, detected, measured or otherwise quantified bythe sensing arrangement 104 communicatively coupled to the infusiondevice 102. However, it should be noted that in alternative embodiments,the condition being regulated may be correlative to the measured valuesobtained by the sensing arrangement 104. That said, for clarity andpurposes of explanation, the subject matter may be described herein inthe context of the sensing arrangement 104 being realized as a glucosesensing arrangement that senses, detects, measures or otherwisequantifies the user's glucose level, which is being regulated in thebody 110 of the user by the infusion device 102.

In exemplary embodiments, the sensing arrangement 104 includes one ormore interstitial glucose sensing elements that generate or otherwiseoutput electrical signals having a signal characteristic that iscorrelative to, influenced by, or otherwise indicative of the relativeinterstitial fluid glucose level in the body 110 of the user. The outputelectrical signals are filtered or otherwise processed to obtain ameasurement value indicative of the user's interstitial fluid glucoselevel. In exemplary embodiments, a blood glucose meter 130, such as afinger stick device, is utilized to directly sense, detect, measure orotherwise quantify the blood glucose in the body 110 of the user. Inthis regard, the blood glucose meter 130 outputs or otherwise provides ameasured blood glucose value that may be utilized as a referencemeasurement for calibrating the sensing arrangement 104 and converting ameasurement value indicative of the user's interstitial fluid glucoselevel into a corresponding calibrated blood glucose value. For purposesof explanation, a blood glucose value calculated based on the electricalsignals output by the sensing element(s) of the sensing arrangement 104may alternatively be referred to herein as the sensor glucose value, thesensed glucose value, or variants thereof.

In the illustrated embodiment, the control module 112 generallyrepresents the electronics and other components of the infusion device102 that control operation of the fluid infusion device 102 according toa desired infusion delivery program in a manner that is influenced bythe sensed glucose value indicative of a current glucose level in thebody 110 of the user. For example, to support a closed-loop operatingmode, the control module 112 maintains, receives, or otherwise obtains atarget or commanded glucose value, and automatically generates orotherwise determines dosage commands for operating an actuationarrangement 116 to actuate or otherwise operate a pumping mechanism 120and deliver insulin from the reservoir 108 to the body 110 of the userbased on the difference between a sensed glucose value and the targetglucose value. In other operating modes, the control module 112 maygenerate or otherwise determine dosage commands configured to maintainthe sensed glucose value below an upper glucose limit, above a lowerglucose limit, or otherwise within a desired range of glucose values. Inpractice, the infusion device 102 may store or otherwise maintain thetarget value, upper and/or lower glucose limit(s), and/or other glucosethreshold value(s) in a data storage element accessible to the controlmodule 112.

The target glucose value and other threshold glucose values may bereceived from an external component or be input by a user via a userinterface element 140 associated with the infusion device 102. Inpractice, the one or more user interface element(s) 140 associated withthe infusion device 102 typically include at least one input userinterface element, such as, for example, a button, a keypad, a keyboard,a knob, a joystick, a mouse, a touch panel, a touchscreen, a microphoneor another audio input device, and/or the like. Additionally, the one ormore user interface element(s) 140 include at least one output userinterface element, such as, for example, a display element (e.g., alight-emitting diode or the like), a display device (e.g., a liquidcrystal display or the like), a speaker or another audio output device,a haptic feedback device, or the like, for providing notifications orother information to the user. It should be noted that although FIG. 1depicts the user interface element(s) 140 as being separate from theinfusion device 102, in practice, one or more of the user interfaceelement(s) 140 may be integrated with the infusion device 102.Furthermore, in some embodiments, one or more user interface element(s)140 are integrated with the sensing arrangement 104 in addition toand/or in alternative to the user interface element(s) 140 integratedwith the infusion device 102. The user interface element(s) 140 may bemanipulated by the user to operate the infusion device 102 to delivercorrection boluses, adjust target and/or threshold values, modify thedelivery control scheme or operating mode, and the like, as desired.

Depending on the embodiment, the control module 112 may be implementedor realized with a general purpose processor, a microprocessor, acontroller, a microcontroller, a state machine, a content addressablememory, an application specific integrated circuit, a field programmablegate array, any suitable programmable logic device, discrete gate ortransistor logic, discrete hardware components, or any combinationthereof, designed to perform the functions described herein. Inexemplary embodiments, the control module 112 includes or otherwiseaccesses a data storage element 114 or memory, including any sort ofrandom access memory (RAM), read only memory (ROM), flash memory,registers, hard disks, removable disks, magnetic or optical massstorage, or any other short or long term storage media or othernon-transitory computer-readable medium, which is capable of storingprogramming instructions for execution by the control module 112. Thecomputer-executable programming instructions, when read and executed bythe control module 112, cause the control module 112 to perform orotherwise support the tasks, operations, functions, and processesdescribed herein. The memory 114 may also store or otherwise maintaintarget glucose values, glucose thresholds, consumable configurationdata, and any other data or information described herein in context ofthe control module 112 and related processes described herein.

In exemplary embodiments, the actuation arrangement 116 includes a motor117 that is operable to displace, actuate or otherwise operate a pumpingmechanism 120 and provide a desired amount of fluid from the reservoir108 to the body 110 of the user. In the illustrated embodiment, themotor 117 engages the pumping mechanism 120 via one or more driveelement(s) 119, however, in some embodiments, the motor 117 may engagethe pumping mechanism 120 directly. The drive element(s) 119 may includelinkages, gears, or other components configured to translate rotationalmotion of a rotor of the motor 117 into a translational displacement orother movement that provides actuation of the pumping mechanism 120.Additionally, although FIG. 1 depicts the pumping mechanism 120 as beingseparate from the infusion device 102 and integrated with the consumable106, in alternative embodiments, one or more aspects of the pumpingmechanism 120 may be integrated with the infusion device 102 and/or theactuation arrangement 116. That said, the subject matter may bedescribed herein primarily in the context of the pumping mechanism 120being integrated with the consumable 106 and/or the reservoir 108.

The illustrated pumping mechanism 120 interfaces or engages a conduit121 for fluid exiting the reservoir 108, and the pumping mechanism 120is configured so that actuation of the pumping mechanism 120 dispensesfluid from the reservoir 108 via the conduit 121 and results in thedelivery of the fluid to the body 110 of the user via a fluid deliverypath provided by an infusion arrangement 122. In this regard, theinfusion arrangement 122 may include one or more tubes, needles,cannulas, infusion sets, or the like that provides a path for fluidcommunication from the exit conduit 121 of the reservoir 108 to the body110 of the user. The control module 112 commands, signals, or otherwiseoperates the motor 117 (or a driver associated therewith) to cause therotor of the motor to rotate by an amount that produces a correspondingamount of actuation of the pumping mechanism 120 (via a drive element(s)119) that results in the delivery of a commanded dosage of fluid fromthe reservoir 108. For example, the control module 112 may determine anamount of actuation of the pumping mechanism 120 that achieves acommanded dosage based on pumping mechanism calibration data asdescribed below, and then determine a corresponding amount of rotationof the rotor required to produce that amount of actuation of the pumpingmechanism 120.

In exemplary embodiments, the control module 112 receives or otherwiseobtains configuration data or information pertaining to the currentconsumable 106 and utilizes the configuration data to calculate theamount of actuation of the pumping mechanism 120 required to deliver acommanded dosage of fluid, and then determines a corresponding amount ofactuation of the actuation arrangement 116 and/or motor 117 to achievethat commanded delivery of fluid. In this regard, the configuration datamay include calibration data that characterizes or quantifies therelationship between an amount of actuation of the pumping mechanism 120and a corresponding amount of fluid delivered from the reservoir 108 fora given consumable 106. Additionally, the configuration data may includephysical measurement data associated with one or more elements orcomponents of the pumping mechanism 120, such as, for example, thelinear dimension of a piston pump chamber, the inner diameter orcircumference of piston pump chamber, the inner diameter orcircumference of a fluid conduit or tubing associated with the pumpingmechanism 120, and the like. In this regard, some embodiments mayutilize the measurements of physical dimensions associated with thepumping mechanism 120 in concert with calibration data associated withthe pumping mechanism 120 to improve the precision or accuracy of fluiddelivery associated with operation of the pumping mechanism 120. Inexemplary embodiments, the infusion device 102 includes an interface 118coupled to the control module 112 that is configured to read orotherwise obtain the configuration data associated with the consumable106 from a readable element 124 integrated or incorporated with theconsumable 106. That said, in some embodiments, the configuration dataassociated with the consumable 106 may be input or provided via a userinterface element 140.

It should be appreciated that any number of potential combinations ofreadable elements 124 and corresponding interfaces 118 may be utilizedin a practical embodiment of the infusion system 100. For example, inone embodiment, the readable element 124 is realized as a radiofrequency identification (RFID) tag integrated with the consumable 106,where the interface 118 is realized as an RFID reader. In anotherembodiment, the readable element 124 is realized as a barcode providedon or otherwise integrated with a surface of the consumable 106, wherethe interface 118 is realized as a barcode scanner. In anotherembodiment, the readable element 124 may be realized as a data storageelement (e.g., an EEPROM or other readable memory) that is coupled to anelectrical bus, one or more electrical terminals, or anothercommunications interface that engages with a correspondingcommunications interface 118 of the infusion device 102 when theconsumable 106 is engaged with or coupled to the infusion device 102.For example, in one embodiment, the interface 118 supports wirelesscommunications with a corresponding communications interface of theconsumable 106, and the control module 112 is configured toautomatically establish wireless communications with the consumable 106when the consumable is within communications range and engaged with theinfusion device 102 to wirelessly retrieve or receive the calibrationdata from the readable element 124. That said, it should be appreciatedthat the subject matter described herein is not intended to be limitedto any particular type of readable, detectable, or otherwiseidentifiable element and corresponding interface. In one or moreexemplary embodiments, the calibration data is maintained by thereadable element 124 in an encrypted form that is capable of beingdecrypted by the control module 112 of the infusion device 102 using oneor more keys stored or otherwise maintained in memory 114.

It should be appreciated that FIG. 1 is a simplified representation ofthe infusion device 102 for purposes of explanation and is not intendedto limit the subject matter described herein in any way. In this regard,depending on the embodiment, some features and/or functionality of thesensing arrangement 104 may implemented by or otherwise integrated intothe control module 112, or vice versa. Furthermore, some of the featuresand/or functionality of the control module 112 may be implemented by aremote computing device that is physically distinct and/or separate fromthe infusion device 102, such as, for example, a computing device, amobile device, a server, or the like.

FIG. 2 depicts an exemplary control process 200 suitable forimplementation by a control system associated with an electronic device,such as a control module 112 in an infusion device 102, to adaptivelycontrol operation of the device based on calibration informationassociated with a current consumable. The various tasks performed inconnection with the control process 200 may be performed by hardware,firmware, software executed by processing circuitry, or any combinationthereof. For illustrative purposes, the following description refers toelements mentioned above in connection with FIG. 1. In practice,portions of the control process 200 may be performed by differentelements of an infusion system 100, however, for purposes ofexplanation, the control process 200 may be described herein primarilyin the context of the infusion device 102 and the control module 112. Itshould be appreciated that the control process 200 may include anynumber of additional or alternative tasks, the tasks need not beperformed in the illustrated order and/or the tasks may be performedconcurrently, and/or the control process 200 may be incorporated into amore comprehensive procedure or process having additional functionalitynot described in detail herein. Moreover, one or more of the tasks shownand described in the context of FIG. 2 could be omitted from a practicalembodiment of the control process 200 as long as the intended overallfunctionality remains intact.

The illustrated control process 200 receives or otherwise obtains thecalibration information associated with the consumable currently engagedwith the infusion device, receives or otherwise obtains measurement dataassociated with the physiological condition being controlled orregulated by the infusion device, and determines or otherwise generatescommands for operating the infusion device to deliver fluid based atleast in part on the currently-applicable calibration information andthe measurement data (tasks 202, 204, 206). In this regard, in one ormore embodiments, the control module 112 operates the interface 118 toaccess or otherwise read the readable element 124 to obtain thecalibration data associated with the current consumable 106 each timethe control scheme or operating mode implemented by the control module112 is updated to generate a delivery command. For example, in responseto receiving an updated measurement from the sensing arrangement 104,the control module 112 may automatically operate the interface 118 toread, scan, or otherwise access the calibration data maintained by thereadable element 124. That said, in other embodiments, the controlmodule 112 automatically operates the interface 118 to access, scan, orotherwise read the readable element 124 of the consumable 106 inresponse to an instance of the consumable 106 being inserted into,engaged with, or otherwise coupled to the housing of the infusion device102. For example, some embodiments of the infusion device 102 mayinclude one or more sensors or other elements that are coupled to thecontrol module 112 and configured to detect the presence or engagementof the consumable 106 with the infusion device 102 and provide acorresponding indication to the control module 112. In response toreceiving a signal or indication of a consumable 106 being engaged withthe infusion device 102, the control module 112 automatically operatesthe interface 118 to read, scan, or otherwise access the calibrationdata maintained by the readable element 124.

In one or more exemplary embodiments, the control module 112 calculatesor otherwise determines an amount or rate of fluid to be delivered fromthe reservoir 108 based on a relationship between the measurementvalue(s) received from the sensing arrangement 104 and one or moretarget or reference values for the physiological condition of the user.For example, for closed-loop glucose control, the control module 112determines an amount of insulin to be delivered based on the differencebetween a current sensed glucose measurement value received from thesensing arrangement 104 and a target glucose measurement value for theuser. After the desired (or commanded) dosage of insulin is determined,the control module 112 calculates or otherwise determines acorresponding amount of actuation of the pumping mechanism 120 thatprovides that desired dosage based on the calibration data associatedwith the consumable 106. In this regard, the calibration data mayinclude a conversion factor for converting a dosage value from units ofinsulin to a corresponding amount of actuation (or number of actuationincrements) of the pumping mechanism 120 and/or the actuationarrangement 116. In some embodiments, the control module 112 may utilizeadditional calibration information associated with the actuationarrangement 116 and/or the motor 117 to convert an amount of actuationof the pumping mechanism 120 to a corresponding amount of actuation (ornumber of actuation increments) of the actuation arrangement 116 and/orthe motor 117. The resulting delivery command determined by the controlmodule 112 using the consumable calibration data represents a commandedamount of actuation of the actuation arrangement 116 and/or the motor117, which produces a corresponding amount of actuation of the pumpingmechanism 120 engaged with the exit conduit 121 of the reservoir 108 todispense the commanded dosage amount of insulin from the reservoir 108to the infusion arrangement 122.

In exemplary embodiments, the loop defined by tasks 204, 206, and 208repeats indefinitely until an instance of the consumable is removed(e.g., when the reservoir 108 becomes depleted) and replaced with a newinstance of the consumable. Thereafter, in response to detecting orotherwise identifying a new instance of the consumable being utilizedwith the infusion device, the control process 200 continues by receivingor otherwise obtaining updated calibration information associated withthe new consumable currently engaged with the infusion device anddetermines or otherwise generates commands for operating the infusiondevice to deliver fluid based at least in part on the updatedcalibration information and the subsequently-received measurement data(tasks 204, 206, 208, 210). For example, in embodiments where theinfusion device 102 includes a sensor that detects or otherwiseidentifies presence of a consumable 106, the control module 112 mayautomatically detect the removal of a first consumable 106 and insertionof a second consumable 106 based on the output of the sensor, and inresponse, operate the interface 118 to retrieve updated calibration dataassociated with the new instance of the consumable 106 in a similarmanner as described above. That said, other embodiments may access,scan, or otherwise read the readable element 124 to obtain updatedcalibration data associated with the new consumable 106 on the nextiteration of the control scheme or operating mode implemented by thecontrol module 112 updating the delivery commands (e.g., in response toreceiving an updated measurement from the sensing arrangement 104).

The loop defined by tasks 204, 206, and 208 may again repeat until thecurrent instance of the consumable is removed and replaced with a newinstance of the consumable. In this regard, each time the consumable ischanged, the calibration data and/or conversion factor(s) utilized bythe control module 112 to convert a commanded dosage of insulin into acorresponding commanded actuation of the actuation arrangement 116and/or motor 117 is updated to reflect the current instance of theconsumable 106. In this manner, the control process 200 is adaptive andaccounts for variations in the physical characteristics of the currentinstance of the consumable 106 relative to preceding instances of theconsumable 106. For example, the dimensions of the conduit 121 for fluidexiting the reservoir 108 which is engaged with the pumping mechanism120 and/or the infusion arrangement 122 may vary from one instance ofthe consumable 106 to the next, which, in turn, results in variations inthe amount or rate of insulin delivered per unit of actuation of thepumping mechanism 120 that engages with the exit conduit 121. Thus,adaptively updating the calibration data facilitates maintaining preciseor accurate delivery of insulin from different instances of theconsumable 106 regardless of the fluid conduit 121 dimensions.

FIG. 3 depicts an exemplary calibration process 300 for determiningcalibration information associated with a consumable and maintaining theassociation of the calibration information with the consumable. Thevarious tasks performed in connection with the calibration process 300may be performed by hardware, firmware, software executed by processingcircuitry, or any combination thereof. For illustrative purposes, thefollowing description refers to elements mentioned above in connectionwith FIG. 1. In practice, portions of the calibration process 300 may beperformed by different elements of an infusion system 100, however, forpurposes of explanation, the calibration process 300 may be describedherein primarily in the context of the infusion device 102 and thecontrol module 112. It should be appreciated that the calibrationprocess 300 may include any number of additional or alternative tasks,the tasks need not be performed in the illustrated order and/or thetasks may be performed concurrently, and/or the calibration process 300may be incorporated into a more comprehensive procedure or processhaving additional functionality not described in detail herein.Moreover, one or more of the tasks shown and described in the context ofFIG. 3 could be omitted from a practical embodiment of the calibrationprocess 300 as long as the intended overall functionality remainsintact.

In exemplary embodiments, the calibration process 300 actuates orotherwise operates a reference drive system engaged with the pumpingmechanism consumable being calibrated to achieve some reference amountof actuation of the pumping mechanism and monitors or otherwise measuresthe response of the consumable to the reference actuation of the pumpingmechanism (tasks 302, 304). In this regard, the consumable 106 beingcalibrated may be configured or otherwise arranged so that its pumpingmechanism 120 engages or otherwise interfaces with a reference instanceof the actuation arrangement 116, which is then actuated by somereference amount to impart a corresponding force or action on thepumping mechanism 120 and/or the fluid conduit 121 exiting the reservoir108. For example, depending on the embodiment, the reference amount ofactuation could correspond to a single revolution of a rotor of themotor 117 or the pumping mechanism 120, a single stroke or instance oflinear motion of the drive element(s) 119 or the pumping mechanism 120,or some other increment of actuation. In this regard, some embodimentsof the pumping mechanism 120 may be calibrated for fractionalrevolutions or rotations, partial strokes, or the like.

A sensing element may be provided downstream of the pumping mechanism120 to quantify, sense, or otherwise measure the fluid response to thereference amount of actuation. For example, the exit conduit 121,pumping mechanism 120, and/or a reference infusion arrangement 122 mayreceive or otherwise be equipped with a flow meter that measures a rateor amount of fluid dispensed via the exit conduit 121 in response to thereference actuation of the pumping mechanism 120. In this regard,depending on the embodiment, the fluid may be the fluid to be dispensedfrom the reservoir (e.g., insulin) or some other reference fluid (e.g.,ambient air from an empty reservoir). For example, the reservoir 108 maybe filled with the fluid to be dispensed after calibration of theconsumable 106. It should be appreciated that for embodiments where thedispensed fluid during calibration (e.g., air) is different from thefluid to be delivered during subsequent operation (e.g., insulin), oneor more conversion factors may be applied to the measured fluid flow tomore accurately characterize the likely response of the operative fluidto the reference amount of actuation. As another example, a pressuresensor may be provided downstream of the pumping mechanism 120 tomeasure an increase in pressure in response to the reference actuationof the pumping mechanism 120, which, in turn, may be converted from apressure measurement to a corresponding amount of fluid delivery. Itshould be appreciated that numerous different techniques for measuringthe fluid response to the reference actuation of the pumping mechanism,and the subject matter described herein is not intended to be limited toany particular manner of calibrating the consumable 106.

The calibration process 300 continues by calibrating the consumablebased on the relationship between the measured response and thereference actuation and storing or otherwise maintaining the calibrationdata in association with the consumable (tasks 306, 308). For example,the control module 112 associated with the reference instance of thepumping mechanism 120 may receive or otherwise obtain the measuredresponse to the reference actuation of the pumping mechanism 120 andthen calculate or otherwise determine one or more calibration conversionfactors for converting an amount of actuation of the pumping mechanism120 to a corresponding amount of fluid dispensed from the consumable106. In this regard, it should be noted that in practice, any number ofinstances of reference actuations and measured responses may be utilizedin determining the calibration data associated with a particularconsumable 106, for example, by averaging the measured responses orperforming other statistical processes to improve the accuracy orreliability of the resulting calibration data.

Once the calibration data associated with the consumable 106 isdetermined, the calibration data is stored or otherwise maintained bythe readable element 124 associated with the consumable 106. Forexample, a control module 112 associated with the reference instance ofthe pumping mechanism 120 may operate an associated interface 118 towrite or otherwise store the calibration data to the readable element124 of the consumable 106. That said, in other embodiments, the readableelement 124 may be configured to store or maintain the calibration databefore being coupled to or otherwise engaged with the consumable 106. Inyet other embodiments, the calibration data may be printed, impressed,embossed, or otherwise transferred to the housing of the consumable 106to achieve the readable element 124. In one or more embodiments, thecalibration data is maintained by the readable element 124 in anencrypted form that may be decrypted by a control module 112 of aninfusion device 102 using one or more cryptographic keys, which may bestored locally onboard the infusion device 102 (e.g., in memory 114) orremotely and retrieved via a network in accordance with a key exchangeprocedure.

In one or more embodiments, physical measurements of one or moreelements or components of the pumping mechanism 120 may also be obtainedduring the calibration process 300 and stored or otherwise be maintainedby the readable element 124 in addition to the calibration data. Forexample, a diameter or other dimension of a fluid path or chamberassociated with the pumping mechanism 120 (e.g., the length or lineardimension of a piston pump chamber, the inner diameter or circumferenceof piston pump chamber, the inner diameter or circumference of a fluidconduit or tubing of a peristaltic pump, or the like) may be measuredand then stored or maintained by the readable element 124. Providingmeasurement data on the readable element 124 supports embodiments wherethe control module 112 utilizes measurements of physical dimensionsassociated with the pumping mechanism 120 in concert with calibrationdata associated with the pumping mechanism 120 to improve the precisionor accuracy of fluid delivery associated with operation of the pumpingmechanism 120.

After the consumable 106 is configured with a readable element 124maintaining the determined calibration data and a reservoir 108containing the operative fluid to be dispensed, the consumable 106 maybe deployed and utilized with an instance of the infusion device 102.That is to say, the control process 200 of FIG. 2 may be employed by aninfusion device 102 that is coupled to or otherwise engaged with aconsumable 106 calibrated in accordance with the calibration process 300of FIG. 3 using a reference instance of the infusion device 102.

FIG. 4 depicts an exemplary embodiment of an infusion device 400 andconsumable 406 suitable for use in the infusion system 100 of FIG. 1 inconjunction with the control process 200 of FIG. 2, where the pumpingmechanism 420 (e.g., pumping mechanism 120) is integrated orincorporated with the consumable 406.

The infusion device 400 includes a housing 402 having a cutout or voidedportion 404 that is contoured to conform to the housing 410 of theconsumable 406. In this regard, the consumable 406 may be inserted intothe cutout portion 404 of the infusion device housing 402 to engage orotherwise couple the consumable 406 to the infusion device 400. Inpractice, the housing 402 may include one or more features configured tosecure or otherwise fix the consumable 406 in an engaged position duringoperation of the infusion device 400.

The infusion device 400 includes an exposed drive element 416 that isconfigured to engage with the pumping mechanism 420 of the consumable406. In this regard, the drive element 416 may be a component of a driveelement(s) 119 that engages with the pumping mechanism 420 to actuatethe pumping mechanism 420 in response to actuation of a motor 117 housedor otherwise contained within the infusion device housing 402. Forexample, the drive element 416 may be realized as a shaft or linkagethat protrudes from the infusion device housing 402 into a voided areadefined by the cutout portion 404 at a location corresponding to thedrive mechanism 420 when a consumable 406 is inserted in the housing402. In this regard, the consumable housing 410 and/or the drivemechanism 420 may include a port or receptacle 423 configured to receivethe drive element 416 that is aligned with the drive element 416 whenthe consumable 406 is engaged with the infusion device 400.

The infusion device 400 also includes an exposed interface 418 (e.g.,interface 418) that is adjacent or otherwise proximate to the cutoutportion 404 at a location aligned with a readable element (or acorresponding interface 428 thereto) associated with the consumable 406.For example, the interface 418 may be realized as one or more pins,pads, ports, wires, or other electrical interconnects that areintegrated with the surface of the cutout portion 404 of the infusiondevice housing 402 and configured to mate, engage, or otherwiseinterface with a corresponding interface 428 provided on or otherwiseintegrated with an opposing surface of the consumable housing 410. Insuch embodiments, the readable element 124 may be realized as a datastorage element or memory (e.g., an EPROM) that is housed or otherwisecontained within the consumable housing 410 and capable of being read bya control module 112 housed or contained within the infusion devicehousing 402 via the interfaces 418, 428. That said, in otherembodiments, the interface 418 may be realized as an RFID reader, abarcode scanner, or some other interface capable of reading orretrieving configuration data maintained on or in the consumable housing410 without utilizing the interface 428. For example, an RFID tag may beintegrated within or affixed to the consumable housing 410 at acorresponding location so that the configuration data may be read fromthe RFID tag by an RFID reader interface 418 when the consumable 406 isinserted into the infusion device housing 402.

Still referring to FIG. 4, the consumable housing 410 is configured tohouse, support, or otherwise retain a fluid reservoir 408 that is influid communication with an infusion arrangement 422 via an exit conduit421 and the pumping mechanism 420. For example, in one embodiment, thepumping mechanism 420 is realized as a piston pump that includes asuction port (or inlet) that mates or engages with the exit conduit 421to receive fluid from the reservoir 408 and a discharge port (or outlet)that mates or engages with the infusion arrangement 422 to dispense orotherwise deliver fluid in response to actuation of the piston. In thisregard, the calibration data associated with the consumable 406 mayaccount for variations in the dimensions of the exit conduit 421, thesuction and/or discharge ports of the piston, and/or the chamber of thepiston pump. Thus, while different amounts of fluid may be dispensed bythe pumping mechanism 420 in response to a single stroke (or incrementalstroke) of the piston across various instances of the consumable 406,the calibration data associated with the current consumable 406 may beutilized by the control module 112 of the infusion device 102, 400 toadjust actuation or operation of the actuation components 116, 117, 119,416 to achieve a desired dosage of fluid delivery as described above.

For example, using the respective calibration data associated withdifferent instances of the consumable 406, the control module 112 maygenerate commands for actuating one instance of the pumping mechanism420 that delivers 0.5 units of insulin in a full stroke by 10% of astroke to achieve a desired insulin delivery of 0.05 units, while foranother instance of the pumping mechanism 420 that delivers 0.55 unitsof insulin in a full stroke, the control module 112 generates commandsfor actuating that instance of the pumping mechanism 420 by 9% of astroke to achieve a desired insulin delivery of 0.05 units. Thus,variations associated with the pumping mechanism 420 of the consumables406 (e.g., when an instance of the pumping mechanism 420 designed orintended to deliver 0.5 units of insulin in a full stroke actuallydelivers 0.55 units of insulin per stroke after fabrication) may becompensated for using the calibration data, thereby relaxing toleranceswhen manufacturing the pumping mechanisms 420 and/or consumables 406.

Similarly, the control module 112 may utilize the calibration data toaccommodate different consumables 406 supporting different volumes orrates of fluid delivery or otherwise having differently sized pumpingmechanisms 420. For example, when the infusion device 400 receives aninstance of the consumable 406 that delivers 1.0 units of insulin in afull stroke, the control module 112 may generate commands for actuatingits associated pumping mechanism 420 by 5% of a stroke to achieve adesired insulin delivery of 0.05 units. Thus, increased rates or volumesof delivery may be accommodated by merely using a different consumable406.

FIG. 5 depicts an embodiment of a piston pump pumping mechanism 500suitable for use as a pumping mechanism 120, 420 associated withoperation of an infusion device 102, 400 in conjunction with theprocesses 200, 300 described above in the context of FIGS. 1-4. Thepiston pump pumping mechanism 500 includes a crankshaft 502 that engagesa drive element(s) 119, 416 configured to rotate the crankshaft 502 inresponse to rotation of a motor 117 and thereby actuate or displace apiston 504 coupled to the crankshaft 502 within a chamber 506. It shouldbe noted the crankshaft 502 is merely one exemplary mechanism fortranslating rotation of a rotor to a linear displacement, and inpractice, alternative mechanisms may be utilized, such as, for example,a rack and pinion mechanism, a solenoid mechanism, or the like.

A valved inlet port 508 to the chamber 506 receives or otherwise engagesa conduit 421 associated with a reservoir 108, 408 to provide fluidcommunication between the chamber 406 and the reservoir 108, 408. Avalved outlet port 510 of the chamber 506 receives or otherwise engagesan infusion arrangement 122, 422 to provide a path fluid communicationfrom the chamber 406 to the body of a user via the infusion arrangement122, 422. Accordingly, actuation of the crankshaft 502 and the piston504 of the piston pump pumping mechanism 500 to draw fluid from thereservoir 108, 408 into the chamber 506 and then discharge and deliverfluid from the chamber 506 to a user via the infusion arrangement 122,422.

Referring to FIG. 5 with reference to FIGS. 1-4, in one exemplaryembodiment, a consumable 106, 406 including the piston pump pumpingmechanism 120, 420, 500 is calibrated for the amount of fluid dispensedand delivered from the reservoir 108, 408 per stroke of the piston 504(or an increment thereof). For example, the consumable 106, 406 may becalibrated by actuating the crankshaft 502 to actuate the piston 504through its full range of displacement (e.g., by achieving a fullrotation of the crankshaft 502) (e.g., task 302) and then measuring theresponse at the outlet port 510 of the piston pump pumping mechanism120, 420, 500 (e.g., task 304). Thereafter, a calibration conversionfactor associated with that instance of the consumable 106, 406 may bedetermined based on the relationship of the fluid response at the outletport 510 to the amount of actuation of the piston 504 (e.g., task 306)and stored or otherwise maintained by the readable element 124associated with the consumable 106, 406 (e.g., task 308). Additionally,in some embodiments, measurements of one or more physical dimensions ofthe chamber 506 and/or one or more of the ports 508, 510 may be obtainedand stored or otherwise maintained by the readable element 124associated with the consumable 106, 406.

When the consumable 106, 406 is inserted into or engaged with theinfusion device 102, 400, the control module 112 operates the interface118, 418 to read the calibration conversion factor from the consumable106, 406 (e.g., task 202), and then utilizes the calibration conversionfactor to operate the actuation components 116, 117, 119, 416 of theinfusion device 102, 400 and achieve a desired delivery of fluid to theuser via the outlet port 510 and infusion arrangement 122, 422. Forexample, based on one or more sensor glucose measurement values receivedfrom the sensing arrangement 104, the control module 112 may determine adesired dosage of insulin to be delivered to the user. The calibrationconversion factor for the current instance of the piston pump pumpingmechanism 120, 420, 500 associated with the current instance of theconsumable 106, 406 may be utilized to determine a commanded amount ofactuation of the piston pump pumping mechanism 120, 420, 500 to achievethat desired delivery of insulin, as described above in the context ofFIG. 4. Thus, the calibration conversion factor adjusts or otherwiseinfluences the resulting amount of actuation of the piston 504 that iscommanded in a manner that accounts for the physical dimensions andvariations thereof associated with the current instance of the pistonpump pumping mechanism 120, 420, 500, fluid conduit 421, and the likeassociated with the current consumable 106, 406 relative to otherinstances of the consumable 106, 406. Other embodiments may also utilizethe physical measurement data associated with the current instance ofthe consumable 106, 406 to adjust or otherwise augment the amount ofactuation. Thereafter, the control module 112 generates correspondingdelivery commands for operating the actuation components 116, 117, 119,416 to achieve the determined amount of actuation of the piston pumppumping mechanism 120, 420, 500 that results in the desired dosage ofinsulin being delivered.

FIGS. 6-7 depict another exemplary embodiment of an infusion device 600and consumable 606 suitable for use in the infusion system 100 of FIG. 1in conjunction with the control process 200 of FIG. 2. In the embodimentof FIGS. 6-7, the pumping mechanism 620 (e.g., pumping mechanism 120) isrealized as a peristaltic pump mechanism integrated into or incorporatedwith the consumable housing 610.

In a similar manner as described above in the context of FIG. 4, theinfusion device housing 602 includes a cutout or voided portion 604 thatis contoured to conform to the consumable housing 610, such that theconsumable 606 is inserted into the cutout portion 604 of the infusiondevice housing 602 to engage or otherwise couple the consumable 606 tothe infusion device 600. The infusion device 600 also includes anexposed drive element 616 that is configured to engage with the pumpingmechanism 620 of the consumable 606. In the embodiment of FIGS. 6-7, thedrive element 616 is realized as a rotary shaft that engages a rotor 700of the peristaltic pump mechanism 620 to rotate the rotor 700 inresponse to actuation of an actuation arrangement 116 and/or motor 117within the infusion device housing 602. Rollers 704 integrated with orotherwise coupled to the rotor 700 compress portions of the conduit (ortubing) 721 for fluid exiting the reservoir 108 contained within theconsumable housing 610 to dispense fluid in response to rotation of therotor 700. via rollers 704 integrated with or otherwise coupled to therotor 700. In this regard, the tubing 721 provides a path for fluid flowfrom the reservoir 108 to a port or outlet of the consumable housing 610that is configured to receive or otherwise engage an infusionarrangement 622 (e.g., infusion arrangement 122). As the rollers 704compress and traverse the tubing 721 in response to rotation of therotor 700, fluid is drawn into the tubing 721 from the reservoir 108 anddispensed downstream into the infusion arrangement 622. In one exampleembodiment, the shaft 616 is inserted into a central bore 702 of therotor 700, and one or more of the shaft 616 and the rotor 700 includesone or more features configured to fixedly engage or couple the rotor700 to the shaft 616.

Although not illustrated in FIGS. 6-7, in a similar manner as describedabove, the infusion device housing 602 includes an interface 118configured to access a readable element 124 contained within orphysically associated with the consumable housing 610, to read orotherwise retrieve configuration data associated with the consumable606, which may be calibrated in accordance with the calibration process300 of FIG. 3. In this regard, the calibration data associated with theconsumable 606 accounts for variations in the inner diameter andpotentially other dimensions of the tubing 721, potential variationsassociated with the interface between the rollers 704 and the tubing721, or potential variations associated with other components 700, 704of the peristaltic pump mechanism 620. For example, the calibration datamay characterize the amount of fluid delivered or dispensed from thereservoir 108 via the tubing 721 per revolution of the rotor 700. Thus,while different amounts of fluid may be dispensed by the peristalticpump pumping mechanism 620 in response to a single rotation of the rotor700 across various instances of the consumable 606, the calibration dataassociated with the current consumable 606 may be utilized by thecontrol module 112 of the infusion device 102, 400 to adjust actuationor operation of the actuation components 116, 117, 119, 616 to achieve adesired dosage of fluid delivery as described above. In this regard, thecalibration data accounts for variations associated with the innerdiameter of the tubing

FIGS. 8-9 depict another exemplary embodiment of an infusion device 800and consumable 806 suitable for use in the infusion system 100 of FIG. 1in conjunction with the control process 200 of FIG. 2. In the embodimentof FIGS. 8-9, the pumping mechanism 820 (e.g., pumping mechanism 120) isrealized as a peristaltic pump mechanism that includes one or moreelements or components that are integrated into or incorporated with theinfusion device housing 802. In this regard, the consumable housing 810includes a cutout or voided portion 814 that corresponds to theperistaltic pump mechanism 820, such that the rotor 819 of theperistaltic pump mechanism 820 extends into the cutout portion 814 ofthe consumable housing 810 to engage a fluid conduit 821 (or tubing)provided therein when the consumable 806 is inserted into the cutoutportion 804 of the infusion device housing 802. In this regard, theinfusion device 800 includes a rotary shaft 817 extending from theinfusion device housing 802 into the cutout portions 804, 814, with theshaft 817 being coupled to the rotor 819. The rotor 819 includes rollers816 of the peristaltic pump mechanism 820 that are coupled thereto, andthe rollers 816 compress the tubing 821 housed within the cutout portion814 of the consumable housing 810 when the consumable 806 and theinfusion device 800 are engaged. As the rollers 816 compress andtraverse the tubing 821 in response to rotation of the rotor 819 andshaft 817, fluid is drawn into the tubing 821 from the reservoir 108 anddispensed downstream via the infusion arrangement 822.

As described above, the consumable 806 may be calibrated in accordancewith the calibration process 300 of FIG. 3 prior to mating or engagingthe consumable 806 with the infusion device housing 802. The infusiondevice housing 802 includes an interface 118 configured to access areadable element 124 contained within or physically associated with theconsumable housing 810, to read or otherwise retrieve the configurationdata associated with the consumable 806 and then operate the peristalticpump mechanism 120, 820 in accordance with the configuration data in asimilar manner as described above in the context of the control process200 of FIG. 2. Thus, the calibration data associated with the consumable806 accounts for variations in the dimensions of the tubing 821 (e.g.,the inner diameter) and/or potentially other fluid path components ofthe consumable 806, thereby allowing the control module 112 of theinfusion device 102, 400 to adjust actuation or operation of theactuation components 116, 117, 119, 817 to adapt to the current instanceof the consumable 806 and achieve a desired dosage of fluid delivery asdescribed above.

Again, it should be noted that in practice there are numerous differenttypes of pumping mechanisms which may be utilized with an infusiondevice, and numerous different types of integration or packaging schemeswhich may be utilized to distribute actuation of the pumping mechanismacross one or more of the infusion device and the consumable.Accordingly, the subject matter described herein is not intended to belimited to any particular type of pumping mechanism, nor any particularmanner of implementing or integrating the pumping mechanism with eitherof the infusion device or the consumable. Regardless of the particularimplementation, the control process 200 of FIG. 2 and the calibrationprocess 300 of FIG. 3 may be performed to adaptively control operationsof the infusion device to deliver fluid in a manner that accounts forvariations in the dimensions or other physical characteristics of thevarious instances of a consumable that may be utilized with the infusiondevice.

FIG. 10 depicts a simplified representation of a fluid delivery system1000 suitable for implementation in an infusion system 100 and usage inconjunction with the processes 200, 300 described above. The fluiddelivery system 1000 includes a pumping mechanism 1020 arranged betweena reservoir 1008 and an output interface 1022 to an infusion set topump, deliver, or otherwise dispense fluid from the reservoir 1008 to abody of a user via the infusion set in response to operation oractuation of a drive system 1016. In this regard, the drive system 1016may include one or more motors or other actuators, gear reducers orother gearing or transmission components, and the like. In exemplaryembodiments, the reservoir 1008 and the pumping mechanism 1020 areintegrated or otherwise embodied in a consumable that engages with aninfusion device, which includes an instance of the drive system 1016, asdescribed above.

As described above in the context of FIG. 3, the embodiment of FIG. 10includes a sensing arrangement 1050 configured to measure a fluidresponse to actuation of the drive system 1016, and thereby calibrate orotherwise characterize the relationship between actuation of a drivesystem 1016 and the rate or amount of fluid delivered by the instance ofthe consumable including the pumping mechanism 1020 being calibrated.The sensing arrangement 1050 could be realized as a flow meter or volumesensor, a pressure sensor, or another suitable sensor capable ofquantifying a fluid response. In the illustrated embodiment, the sensingarrangement 1050 is provided downstream of the pumping mechanism 1020,and in some embodiments, the sensing arrangement 1050 is provideddownstream of the output interface 1022 to obtain a measured responsethat accounts for variations associated with the pumping mechanism 1020,the output interface 1022, and any tubing or other components that maybe part of the fluid path from the reservoir 1008 to the outputinterface 1022. The sensing arrangement 1050 is also capable of beingdetachably or selectively coupled to the downstream fluid path, so thatthe sensing arrangement 1050 can be disengaged from a consumable once itis calibrated and subsequently reused to calibrate other instances ofthe consumable. Similarly, a reference drive system 1016 may bedisengaged or decoupled from the consumable once it is calibrated andsubsequently reused to calibrate other instances of the consumable.

In alternative embodiments, the sensing arrangement 1050 (or anadditional second sensing arrangement) may be provided upstream of thepumping mechanism 1020 but downstream of the reservoir 1008. Inembodiments where multiple sensing arrangements 1050 are employed bothupstream and downstream of the pumping mechanism 1020, the measuredresponses obtained from the different sensing arrangements 1050 may beaveraged or otherwise combined to obtain an average measured response toactuation of the pumping mechanism 1020. It should be noted that asensing arrangement upstream of the pumping mechanism 1020 may beutilized to detect depletion of the reservoir 1008 during calibration(e.g., when to cease actuating the drive system 1016 and/or obtainingmeasured responses), while a sensing arrangement downstream of thepumping mechanism 1020 may be utilized to detect an occlusion in thefluid path. In some embodiments, a consumable may be discarded inresponse to detection of a fluid path occlusion when the occlusioncannot be remediated or removed.

It should be noted that the type of sensing arrangement 1050 employedduring manufacturing for calibration purposes may be different fromsensing arrangements that may be part of the consumable or the infusiondevice and used during subsequent operation. For example, the sensingarrangement 1050 may be realized as a relatively high sensitivitypressure sensor that measures pressure response to actuation of thepumping mechanism 1020 to determine a corresponding amount of fluiddelivered per unit of actuation of the pumping mechanism 1020 (e.g., acalibrated stroke volume of a piston pumping mechanism). Thereafter, theconsumable or infusion device may be equipped with or otherwise employ aforce sensor, an optical sensor, or the like that is then used duringoperation to detect occlusion conditions, reservoir depletion, or otherconditions that may be exhibited by the consumable during operation ofthe infusion device. In this regard, by virtue of the calibrationdescribed herein, the consumable does not necessarily need to beequipped with a flow meter or other sensors for measuring fluiddelivery.

During or after the manufacturing of the consumable including thepumping mechanism 1020 and reservoir 1008, a reference instance of thedrive system 1016 is operated to actuate the pumping mechanism 1020 bysome reference amount, and a corresponding fluid response is measured,quantified, or otherwise obtained via the sensing arrangement 1050.Based on the relationship between the measured fluid response and theactuation of the drive system 1016 and/or pumping mechanism 1020, thecalibration data associated with the consumable characterizing therelationship between actuation of the pumping mechanism 1020 and theresulting fluid delivery is determined.

After calibration data associated with the consumable is determined, thecalibration data written to or otherwise stored on a readable elementassociated with the consumable. For example, a control module, aprocessing system, or the like, may be coupled to drive system 1016 toprovide the reference amount of actuation, coupled to the sensingarrangement 1050 to receive the measured fluid response, and coupled thereadable element to write or otherwise store calibration data to thereadable element, which was calculated or otherwise determined by thecontrol module based on the relationship between the reference amount ofactuation and the measured fluid response. In some embodiments, physicalmeasurements of aspects of the pumping mechanism 1020 and/or other fluidpath components are obtained (e.g., using an optical measuring device, atouch probe measuring device, or the like) and the correspondingmeasurement data also written to or otherwise stored on a readableelement associated with the consumable.

In some embodiments, the pumping mechanism 1020 may be calibrated duringmanufacturing and prior to assembly in the consumable. For example, thepumping mechanism 1020 may be calibrated without the presence of a fluidreservoir 1008 (e.g., using air) or with a reference instance of thereservoir 1008 that is different from the reservoir 1008 that isultimately packaged with the pumping mechanism 1020 in the consumable.In this regard, an instance of a fluid reservoir 1008 may be provided orotherwise packaged within a housing of the consumable, and then aftercalibration of an instance of the pumping mechanism 1020, that instanceof the pumping mechanism 1020 may be provided or otherwise packagedwithin the housing and configured so that the pumping mechanism 1020 isin fluid communication with the reservoir 1008 to thereby provide a pathfor fluid flow from the reservoir 1008 via the pumping mechanism 1020.In one embodiment, a barcode representation of the calibration data isprinted or otherwise provided on an external surface of the housing ofthe consumable. In another embodiment, the calibration data is writtento or otherwise stored on a RFID tag, which may be packaged or containedwithin the housing of the consumable or integrated with an externalsurface of the housing. In another embodiment, the calibration data iswritten to or otherwise stored on a data storage element that ispackaged or contained within the housing. Depending on the embodiment,the readable element may be configured or packaged with the consumablehousing either before or after packaging the pumping mechanism 1020and/or the reservoir 1008 within the consumable housing.

After manufacturing, the consumable may be engaged with an infusiondevice which is configured to read the calibration data, measurementdata, and/or other configuration data that was written to the readableelement and adjust actuation of its associated drive system 1016 in amanner that accounts for variations in the dimensions or other physicalcharacteristics of the pumping mechanism 1020 and other fluid pathcomponents of the consumable currently being utilized with the infusiondevice. In this manner, actuation of the pumping mechanism 1020 iscorrected or adjusted to achieve a desired delivery of fluid withgreater precision across different consumables. In particular, someembodiments may utilize the calibration data in conjunction with thephysical measurement data to fine tune the actuation, for example, byadjusting actuation commands based on a function of the calibration datafor the fluid response to actuation of the pumping mechanism 1020 andthe dimensions or other physical measurements of the pumping mechanism1020. Since fluid volume accuracy may be a function of dimensions of thepumping mechanism 1020 (which are captured by the measurement data) aswell as the mechanics of the pumping mechanism 1020 (which are capturedby the calibration data), adjusting actuation based on configurationdata that includes both fluid response calibration data and physicalmeasurement data may improve accuracy and reliability across a widerange of consumables and across a wide range of delivery or dosageamounts (or rates).

While the subject matter is described above primarily in the context ofa consumable containing an insulin reservoir for regulating a glucoselevel of a user, the subject matter described herein is not limited toany type of media dispensed from or otherwise provided by theconsumable, and the subject matter may be implemented with other medicaldevices or electronic devices other than fluid infusion devices. Forexample, any electronic device could be configured to receive aconsumable component and consume or deliver a medium from the consumablecomponent, where the housing of the consumable component includes areadable element provided on, integrated with, or otherwise physicallyassociated therewith that includes calibration data characterizing arelationship between depletion of the medium and actuation of anactuatable mechanism engaged therewith, thereby enabling a controlmodule or processing system of the device to adaptively control theactuation of the actuatable mechanism in accordance with theconfiguration data.

For the sake of brevity, conventional techniques related to glucosesensing and/or monitoring, closed-loop glucose control, sensorcalibration, electrical signals and related processing, electricalinterconnects or interfaces, packaging, fluid communications, fluidmonitoring or measuring, and other functional aspects of the subjectmatter may not be described in detail herein. In addition, certainterminology may also be used in the herein for the purpose of referenceonly, and thus is not intended to be limiting. For example, terms suchas “first”, “second”, and other such numerical terms referring tostructures do not imply a sequence or order unless clearly indicated bythe context. The foregoing description may also refer to elements ornodes or features being “connected” or “coupled” together. As usedherein, unless expressly stated otherwise, “coupled” means that oneelement/node/feature is directly or indirectly joined to (or directly orindirectly communicates with) another element/node/feature, and notnecessarily mechanically.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. For example, the subject matter described herein isnot necessarily limited to the infusion devices and related systemsdescribed herein. Moreover, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application. Accordingly, details of theexemplary embodiments or other limitations described above should not beread into the claims absent a clear intention to the contrary.

What is claimed is:
 1. A system comprising: a consumable comprising a housing containing a reservoir, a piston pump pumping mechanism for dispensing a fluid from the reservoir, and a readable element maintaining calibration data characterizing a relationship between delivery of the fluid and actuation of the piston pump pumping mechanism, the piston pump pumping mechanism comprising a mechanism for translating rotation to a linear displacement of a piston coupled to the mechanism, the calibration data comprising an amount of the fluid deliverable from the consumable per stroke of the piston; and an infusion device having a portion to receive the housing and including an interface to obtain the calibration data from the readable element, an actuation arrangement configured to actuate the piston pump pumping mechanism and a control module coupled to the interface and the actuation arrangement to determine a delivery command based at least in part on the amount of the fluid deliverable from the consumable per stroke of the piston and operate a motor of the actuation arrangement in accordance with the delivery command, wherein the actuation arrangement includes an element configured to rotate the mechanism of the piston pump pumping mechanism and thereby displace the piston in response to rotation of the motor.
 2. The system of claim 1, wherein the mechanism comprises a crankshaft.
 3. The system of claim 2, wherein the calibration data comprises a measured response at an outlet port of the piston pump pumping mechanism to actuating the crankshaft through a full rotation to actuate the piston through its full range of displacement.
 4. The system of claim 1, wherein the mechanism comprises a rack and pinion mechanism or a solenoid mechanism.
 5. The system of claim 1, wherein the amount is influenced by variations in dimensions of at least one component of the piston pump pumping mechanism.
 6. The system of claim 1, wherein the control module determines the delivery command by calculating a number of strokes of the piston to achieve a desired amount of the fluid based the amount of the fluid deliverable from the consumable per stroke of the piston.
 7. The system of claim 1, wherein: the piston pump pumping mechanism comprises a chamber having the piston disposed therein; and the calibration data comprises physical measurement data including at least one of: a linear dimension of the chamber, an inner diameter of the chamber, and an inner circumference of the chamber.
 8. The system of claim 1, wherein the calibration data accounts for physical dimensions associated with the consumable.
 9. An infusion device comprising: a housing including a portion for receiving a second housing of a consumable containing a reservoir and a piston pump pumping mechanism for dispensing a fluid from the reservoir; an interface proximate the portion of the housing to obtain calibration data from the consumable, the calibration data comprising an amount of the fluid deliverable from the consumable per stroke of a piston of the piston pump pumping mechanism, the piston pump pumping mechanism comprising a mechanism for translating rotation to a linear displacement of the piston coupled to the mechanism; an actuation arrangement contained within the housing, the actuation arrangement comprising a motor and an element coupled to the motor and configured to rotate a mechanism of the piston pump pumping mechanism and thereby displace the piston in response to rotation of the motor to dispense the fluid from the consumable; and a control module coupled to the interface and the actuation arrangement to determine a delivery command based at least in part on the amount of the fluid deliverable from the consumable per stroke of the piston and operate the motor in accordance with the delivery command.
 10. The infusion device of claim 9, wherein the interface comprises a radio frequency identification (RFID) reader.
 11. The infusion device of claim 9, wherein the interface comprises a barcode scanner.
 12. The infusion device of claim 9, wherein the interface comprises a bus interface integral with a surface of the portion of the housing.
 13. The infusion device of claim 9, wherein the interface comprises an electrical terminal integral with a surface of the portion of the housing.
 14. A method of operating an infusion device operable to deliver a fluid influencing a physiological condition to a body of a user, the method comprising: obtaining, by a control module of the infusion device via an interface of the infusion device, calibration data associated with a piston pump pumping mechanism of a consumable coupled to the infusion device, the consumable comprising a housing containing a reservoir and the piston pumping mechanism for dispensing the fluid from the reservoir, wherein the infusion device includes a portion to receive the housing of the consumable and the calibration data comprises an amount of the fluid deliverable from the consumable per stroke of a piston of the piston pump pumping mechanism, the piston pump pumping mechanism comprising a mechanism for translating rotation to a linear displacement of the piston coupled to the mechanism; determining, by the control module, a delivery command for delivering the fluid to the body of the user based at least in part on the amount of the fluid deliverable from the consumable per stroke of the piston; and operating, by the control module, an actuation arrangement comprising a motor coupled to an element engaging the piston pump pumping mechanism to rotate a mechanism of the piston pump pumping mechanism and thereby displace the piston in response to rotation of the motor to deliver the fluid from the consumable in accordance with the delivery command.
 15. The method of claim 14, further comprising: obtaining, by the control module, one or more measurement values indicative of the physiological condition in the body of the user from a sensing arrangement; and determining, by the control module, a dosage of the fluid to be delivered based at least in part on the one or more measurement values and a target value for the physiological condition in the body of the user, wherein determining the delivery command comprises the control module determining the delivery command based at least in part on the dosage and the calibration data.
 16. The method of claim 14, the piston pump pumping mechanism being incorporated with the consumable and the infusion device including the actuation arrangement engageable with the piston pump pumping mechanism, wherein: determining the delivery command comprises: determining an amount of actuation of the piston pump pumping mechanism for achieving a dosage of the fluid based at least in part on the calibration data; and determining a commanded amount of actuation of the actuation arrangement to achieve the amount of actuation of the piston pump pumping mechanism; and operating the actuation arrangement comprises operating the actuation arrangement to achieve the commanded amount of actuation.
 17. The method of claim 14, wherein obtaining the calibration data comprises reading the calibration data from a readable element associated with the consumable.
 18. The method of claim 14, wherein obtaining the calibration data comprises retrieving the calibration data via the interface of the infusion device from a corresponding interface of the consumable.
 19. The method of claim 14, wherein obtaining the calibration data comprises receiving the calibration data from the consumable via a communications interface of the infusion device. 